Data / Medical devices / United States / Anumana Inc.
Anumana Inc.: FDA-registered device maker in Cambridge, MA, United States, 4 510(k) clearances
Anumana Inc. is registered with the FDA (registration 3029762850) in Cambridge, MA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 7, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3029762850
- Address
- One Main Street Suite 400, East Arcade, Cambridge, MA, United States, 02142
- Owner or operator
- Anumana Inc. (10088820)
- Roles
- Manufacturer
- First device listed
- October 13, 2023
- Registered through
- 2027
- Brand names listed
- ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm, ECG-AI LEF 12-Lead algorithm, ECG-AI Low Ejection Fraction 12-Lead algorithm, ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cardiac Amyloidosis Machine Learning-Based Notification Software | SHP | 2 | Manufacturer | accessdata.fda.gov |
| Pulmonary Hypertension Machine Learning-Based Notification Software | SAT | 2 | Manufacturer | accessdata.fda.gov |
| Reduced Ejection Fraction Machine Learning-Based Notification Software | QYE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 7, 2026 | K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | SHP | Substantially Equivalent | Anumana, Inc. | accessdata.fda.gov |
| March 28, 2026 | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | SAT | Substantially Equivalent | Anumana, Inc. | accessdata.fda.gov |
| July 28, 2025 | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | QYE | Substantially Equivalent | Anumana, Inc. | accessdata.fda.gov |
| September 28, 2023 | K232699 | Low Ejection Fraction AI-ECG Algorithm | QYE | Substantially Equivalent | Anumana, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pulmonary Hypertension Machine Learning-Based Notification Software
- All makers of Reduced Ejection Fraction Machine Learning-Based Notification Software
Updated April 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.